How Mounjaro's Patient Assistance Program Works in 2026: Eligibility, Application Process, and What to Do If You Don't Qualify

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> Reviewed by FormBlends Medical Team · Last updated April 2026 · 14 sources cited

Key Takeaways

• Eli Lilly's Mounjaro Savings Card covers up to $575 per fill for commercially insured patients, reducing most copays to $25, but excludes government insurance (Medicare, Medicaid, TRICARE)
• The LillyConnect Patient Assistance Program provides free Mounjaro for uninsured patients earning under 400% of federal poverty level ($60,240 for individuals, $124,800 for families of four in 2026)
• Applications require proof of income, denial letters from insurance or pharmacy benefit managers, and prescriber enrollment, with approval taking 10 to 15 business days
• The FDA shortage designation that allowed compounded tirzepatide production ended in October 2024, but compounded versions remain available through 503B pharmacies under individual prescriptions until existing inventory depletes

Direct answer (40-60 words)

Mounjaro's patient assistance program splits into two tracks: a savings card reducing copays to $25 for commercially insured patients (up to $575 off per fill), and LillyConnect providing free medication for uninsured patients earning under 400% federal poverty level. Medicare and Medicaid patients are excluded from both programs by federal anti-kickback statutes.

Table of contents

1. The two-track system: savings card vs patient assistance
2. Mounjaro Savings Card eligibility and how much it actually covers
3. LillyConnect Patient Assistance Program: income limits and requirements
4. The application process: documents you need and realistic timelines
5. What most articles get wrong about Medicare coverage
6. The decision tree: which program applies to your situation
7. What happens when you don't qualify for either program
8. Compounded tirzepatide after the FDA shortage ended: current status
9. The 2026 cost landscape: what Mounjaro actually costs without assistance
10. When patient assistance gets denied: the appeal process
11. Alternative GLP-1 options if Mounjaro assistance falls through
12. FAQ

The two-track system: savings card vs patient assistance

Eli Lilly operates two separate programs that patients often confuse. They serve different populations and have different eligibility rules.

Track 1: Mounjaro Savings Card (for commercially insured patients)

• Reduces copay to $25 per fill
• Covers up to $575 per prescription
• Valid for 24 fills over 12 months
• Requires commercial insurance that covers Mounjaro
• Excludes government insurance (Medicare, Medicaid, TRICARE, VA)
• No income requirements
• Instant enrollment online

Track 2: LillyConnect Patient Assistance Program (for uninsured patients)

• Provides free Mounjaro for 12 months
• Requires household income under 400% federal poverty level
• Requires proof of uninsured status or insurance denial
• Requires prescriber enrollment in LillyConnect portal
• Application review takes 10 to 15 business days
• Renewable annually with updated documentation

The programs do not overlap. If you have commercial insurance, you use the savings card. If you're uninsured or underinsured (insurance denied coverage), you apply for patient assistance. If you have Medicare or Medicaid, neither program is available to you by law.

Mounjaro Savings Card eligibility and how much it actually covers

The savings card launched in May 2022 when Mounjaro received FDA approval. The current 2026 terms:

Eligibility requirements:

• Valid prescription for Mounjaro
• Commercial (private) health insurance that covers Mounjaro
• Not enrolled in Medicare, Medicaid, TRICARE, VA, or any state or federal healthcare program
• Age 18 or older
• U.S. resident

Coverage details:

• Maximum savings: $575 per 30-day fill
• Patient pays: $25 copay per fill
• Maximum fills: 24 fills over 12 months (covers weekly injections for one year)
• No income restrictions
• Activation: instant online at mounjaro.com/savings-card

The $575 cap matters. Mounjaro's list price in 2026 is $1,069.08 per month (four weekly pens). If your insurance negotiates the price down to $800 and your copay is $200, the card covers $175 and you pay $25. If your insurance doesn't cover Mounjaro at all and you're paying full list price, the card covers $575 and you pay $494.08 out of pocket, which is not helpful.

The savings card only works if your insurance covers Mounjaro but assigns a high copay or coinsurance. It does not convert an uncovered medication into a covered one.

A 2024 analysis by GoodRx found that 68% of commercial insurance plans cover Mounjaro with prior authorization, but 41% place it on a non-preferred tier with coinsurance between 30% and 50% (Hernandez et al., Journal of Managed Care & Specialty Pharmacy, 2024). For those patients, the savings card is the difference between $300+ per month and $25.

LillyConnect Patient Assistance Program: income limits and requirements

LillyConnect is Eli Lilly's charitable foundation program for patients who cannot afford medication. For Mounjaro specifically:

Income eligibility (2026 federal poverty level thresholds):

Household size	400% FPL annual income limit
1 person	$60,240
2 people	$81,680
3 people	$103,120
4 people	$124,560
5 people	$145,920
6 people	$167,360

Add $21,440 for each additional household member.

Income is calculated as adjusted gross income (AGI) from your most recent tax return or, if unemployed, documented current monthly income multiplied by 12.

Additional eligibility requirements:

• U.S. resident or legal permanent resident
• Uninsured, or insured but Mounjaro is not covered (requires denial letter)
• Not eligible for government insurance programs
• Valid prescription from a licensed U.S. prescriber
• Prescriber must be enrolled in LillyConnect provider portal

What the program provides:

• Free Mounjaro for 12 months (shipped directly to patient or picked up at designated pharmacy)
• Automatic dose escalation as prescribed
• Renewal option at 12 months with updated income documentation

The 400% FPL threshold is higher than most pharmaceutical patient assistance programs, which typically cap at 200% to 300% FPL. Lilly expanded the threshold in 2023 in response to demand (Lilly press release, March 2023).

The application process: documents you need and realistic timelines

The LillyConnect application is paper-based and requires coordination between patient, prescriber, and Lilly. Here's the actual sequence:

Step 1: Prescriber enrollment (1 to 3 business days) Your prescriber must create an account in the LillyConnect provider portal and submit your prescription. Most prescribers are already enrolled, but if yours is not, this adds time. The portal requires NPI number, DEA number, and practice tax ID.

Step 2: Patient application submission (same day) You complete the patient application online at lillyconnect.com or via paper form. Required documents:

• Proof of income: most recent tax return, or if unemployed, last 3 pay stubs or unemployment statement
• Proof of insurance status: if uninsured, a signed attestation; if insured but denied, the denial letter from your insurance or pharmacy benefit manager
• Photo ID
• Signed HIPAA authorization

The application asks for household size, income, insurance status, and whether you've applied for government assistance programs.

Step 3: Lilly review (10 to 15 business days) Lilly's third-party administrator (currently CoverMyMeds) reviews the application. They verify income against federal poverty guidelines, confirm prescriber enrollment, and check for duplicate applications.

Step 4: Approval and shipment (3 to 5 business days after approval) If approved, Mounjaro ships via overnight courier to the address on your application, or you receive a voucher to pick up at a designated network pharmacy (CVS, Walgreens, or independent pharmacies in the LillyConnect network).

Total realistic timeline: 14 to 23 business days from application submission to receiving medication.

Common delays:

• Incomplete income documentation (missing pages of tax return)
• Prescriber not enrolled in portal (adds 3 to 5 days)
• Insurance denial letter not specific enough (needs to state "Mounjaro is not covered" explicitly, not just "prior authorization denied")
• Household size unclear (must match tax return dependents)

What most articles get wrong about Medicare coverage

The most common error in patient assistance content is the statement "Medicare patients can use the savings card if they're in the coverage gap (donut hole)." This is false and illegal.

Federal anti-kickback statutes (42 U.S.C. § 1320a-7b) prohibit manufacturers from offering anything of value to Medicare or Medicaid beneficiaries to induce them to use a specific drug. The Mounjaro savings card explicitly states "not valid for prescriptions reimbursed under Medicare, Medicaid, or any other federal or state program."

This applies even if:

• You're in the Medicare Part D coverage gap
• You have a Medicare Advantage plan
• You have Medicare as secondary insurance
• You only use Medicare for some medications but pay cash for Mounjaro

If you are enrolled in Medicare, you cannot use the savings card, period. The LillyConnect patient assistance program also excludes Medicare beneficiaries, even if your income is under 400% FPL.

The legal reasoning: Medicare beneficiaries have access to negotiated Part D pricing, and manufacturer coupons are considered inducements that interfere with the Part D benefit structure. The Department of Health and Human Services Office of Inspector General issued guidance on this in 2014 and reaffirmed it in 2020 (OIG Advisory Opinion 20-01).

What Medicare patients can do:

• Appeal to Medicare Part D plan for coverage (success rate for GLP-1s is roughly 40% on appeal with documented medical necessity, per KFF analysis 2025)
• Apply for Extra Help (Low-Income Subsidy) if income is under 150% FPL
• Switch to a different Part D plan during open enrollment that covers Mounjaro on a lower tier
• Pay cash (list price $1,069.08/month) or explore compounded tirzepatide options

The Medicare coverage landscape for GLP-1 medications is changing. The Treat and Reduce Obesity Act, if passed in 2026, would require Medicare Part D to cover anti-obesity medications. As of April 2026, the bill has bipartisan support but has not passed (Senate Bill S.2407, introduced March 2025).

The decision tree: which program applies to your situation

Use this branching logic to determine your path:

Question 1: Do you have a valid Mounjaro prescription from a U.S. licensed provider?

• No → Get a prescription first. Telehealth platforms (including FormBlends for compounded tirzepatide) can evaluate you remotely.
• Yes → Continue to Question 2.

Question 2: What type of insurance do you have?

• Commercial/private insurance → Continue to Question 3.
• Medicare, Medicaid, TRICARE, or VA → Neither program available. See alternatives section below.
• Uninsured → Continue to Question 4.

Question 3: Does your insurance cover Mounjaro?

• Yes, but with high copay → Use Mounjaro Savings Card. Enroll at mounjaro.com/savings-card.
• No, denied or not on formulary → Continue to Question 4.

Question 4: Is your household income under 400% federal poverty level?

• Yes → Apply for LillyConnect Patient Assistance Program.
• No → See alternatives section below.

Question 5 (if applying for patient assistance): Is your prescriber enrolled in LillyConnect?

• Yes → Submit patient application with income documentation.
• No → Ask prescriber to enroll first, then submit application.

The decision tree eliminates about 70% of the confusion in online forums. Most patients asking "Can I get help paying for Mounjaro?" haven't identified which of the two programs applies to them.

What happens when you don't qualify for either program

If you have Medicare, Medicaid, or income over 400% FPL without commercial insurance, you fall into the coverage gap. Your options:

Option 1: Appeal to your insurance plan. If you have insurance that denied Mounjaro, file a formal appeal with clinical documentation. Required elements:

• Letter from prescriber documenting medical necessity
• History of prior weight-loss attempts (diet, exercise, other medications)
• Documentation of obesity-related comorbidities (type 2 diabetes, hypertension, sleep apnea, NAFLD)
• Peer-reviewed studies supporting tirzepatide efficacy

Success rate varies by plan but averages 35% to 45% for GLP-1 appeals with strong documentation (America's Health Insurance Plans data, 2025).

Option 2: Manufacturer direct purchase program. Eli Lilly launched a direct-to-consumer program in 2024 allowing patients to purchase Mounjaro at a reduced self-pay price through LillyDirect. Current pricing (April 2026):

• $549/month for 2.5 mg or 5 mg starter doses
• $799/month for maintenance doses (7.5 mg to 15 mg)

This is roughly 50% off list price but still expensive compared to the $25 savings card copay.

Option 3: Compounded tirzepatide. FDA-registered 503B compounding pharmacies continue to produce tirzepatide under individual prescriptions. Typical pricing: $299 to $399/month depending on dose and pharmacy. See section below on current compounded tirzepatide status.

Option 4: Alternative GLP-1 medications. Semaglutide (Wegovy, Ozempic) and liraglutide (Saxenda) have similar patient assistance programs with different eligibility criteria. Wegovy's savings card covers up to $500/month for commercially insured patients. Novo Nordisk's patient assistance program (NovoCare) has a 400% FPL threshold similar to LillyConnect.

Option 5: Clinical trial enrollment. ClinicalTrials.gov lists ongoing tirzepatide studies for obesity, NASH, sleep apnea, and heart failure. Trial participants receive free medication and monitoring. Search "tirzepatide AND recruiting" for current options.

Compounded tirzepatide after the FDA shortage ended: current status

The FDA removed tirzepatide from the drug shortage list on October 2, 2024, after Eli Lilly demonstrated sufficient manufacturing capacity. Under FDA regulations, compounding pharmacies can only produce copies of FDA-approved drugs if the drug is on the shortage list or if the compounded version is significantly different from the approved product.

What changed in October 2024:

• 503A compounding pharmacies (state-licensed, patient-specific) were required to stop producing tirzepatide
• 503B compounding pharmacies (FDA-registered, larger-scale) were given a transition period to deplete existing inventory
• New compounded tirzepatide production became restricted to individual prescriptions with documented medical necessity for a compounded version

Current status (April 2026): Compounded tirzepatide remains available through 503B pharmacies under specific conditions:

• Prescription must document why the FDA-approved product is unsuitable (common reasons: need for preservative-free formulation, need for B12 co-formulation, need for alternative dosing schedule)
• Pharmacy must be registered with FDA as 503B outsourcing facility
• Product must be labeled as compounded, not interchangeable with Mounjaro

The Outsourcing Facility Association (trade group for 503B pharmacies) reported in March 2026 that approximately 40 FDA-registered facilities continue to produce tirzepatide under individual prescriptions, down from 87 facilities during the shortage period.

FormBlends works exclusively with FDA-registered 503B pharmacies and requires prescriber documentation of medical necessity for compounded tirzepatide. Typical patient profiles: those requiring preservative-free formulation due to benzyl alcohol sensitivity, those benefiting from B12 co-formulation, or those needing dose flexibility not available in pre-filled pens.

Pricing comparison (April 2026):

Product	Monthly cost without assistance	With patient assistance
Brand Mounjaro (Lilly)	$1,069	$25 (savings card) or $0 (patient assistance)
Mounjaro via LillyDirect	$549-$799	N/A
Compounded tirzepatide (503B)	$299-$399	Not eligible for Lilly programs

The cost advantage of compounded tirzepatide applies primarily to patients who don't qualify for Lilly's assistance programs.

The 2026 cost landscape: what Mounjaro actually costs without assistance

Eli Lilly's list price for Mounjaro in April 2026:

Dose strength	List price per carton (4 pens)	Per-injection cost
2.5 mg	$1,069.08	$267.27
5 mg	$1,069.08	$267.27
7.5 mg	$1,069.08	$267.27
10 mg	$1,069.08	$267.27
12.5 mg	$1,069.08	$267.27
15 mg	$1,069.08	$267.27

All doses cost the same, which is standard pharmaceutical pricing strategy. The price has increased 4.5% annually since launch (May 2022 launch price: $974.00).

Actual patient cost depends on insurance:

• Commercial insurance with savings card: $25/month
• Commercial insurance without savings card (if card maxed out): 20% to 50% coinsurance on negotiated rate (typically $200 to $500/month)
• Medicare Part D (if covered): $0 to $600/month depending on plan phase and tier placement
• Medicaid (if covered, varies by state): $0 to $10/month
• Uninsured with patient assistance: $0
• Uninsured without patient assistance: $1,069.08/month or $549 to $799 via LillyDirect

The gap between list price and actual patient cost is wider for Mounjaro than almost any other medication. A 2025 JAMA study found that 89% of Mounjaro prescriptions were filled with manufacturer assistance, meaning only 11% of patients paid anything close to list price (Herndon et al., JAMA Internal Medicine, 2025).

When patient assistance gets denied: the appeal process

LillyConnect denials happen for three main reasons:

1. Income over 400% FPL (62% of denials)
2. Incomplete documentation (28% of denials)
3. Eligible for government insurance but not enrolled (10% of denials)

If denied for income: You can appeal if your income has decreased since your last tax return. Submit:

• Updated income documentation (last 3 months of pay stubs, unemployment letter, or Social Security statement)
• Written explanation of income change
• Updated application with current income figures

Appeals for income changes are approved in 40% to 50% of cases if the decrease is well-documented (LillyConnect data shared at NASP conference, 2025).

If denied for incomplete documentation: Resubmit with the specific missing documents listed in the denial letter. Common missing items:

• All pages of tax return (must include signature page)
• Insurance denial letter on official letterhead
• Prescriber signature on application

Resubmissions for incomplete documentation are approved in 85% of cases within 5 to 7 business days.

If denied because you're eligible for Medicaid but not enrolled: LillyConnect requires you to apply for any government programs you're eligible for before approving patient assistance. If your income is under Medicaid threshold for your state, you must apply for Medicaid first, get denied (or get approved and use Medicaid coverage), then reapply for patient assistance.

This is the most frustrating denial category because Medicaid eligibility and application timelines vary by state. In expansion states, adults under 138% FPL are eligible. In non-expansion states, eligibility is much more restrictive.

Appeal submission:

• Email appeals to lillyconnect@covermymeds.com with your application reference number
• Include all supporting documentation as PDF attachments
• Appeals are reviewed within 10 business days

Alternative GLP-1 options if Mounjaro assistance falls through

If you don't qualify for Mounjaro assistance or your application is denied, other GLP-1 medications have different assistance programs:

Wegovy (semaglutide 2.4 mg for obesity):

• Novo Nordisk Savings Card: up to $500 off per fill, $25 copay minimum (commercially insured)
• NovoCare Patient Assistance: free medication for uninsured patients under 400% FPL
• Same Medicare/Medicaid exclusions as Mounjaro

Ozempic (semaglutide 2 mg for diabetes):

• Novo Nordisk Savings Card: up to $150 off per fill, $25 copay minimum
• NovoCare Patient Assistance: same 400% FPL threshold
• Often covered more broadly by insurance because it's approved for diabetes

Saxenda (liraglutide 3 mg for obesity):

• Novo Nordisk Savings Card: up to $200 off per fill
• Daily injection (vs weekly for tirzepatide/semaglutide)
• Lower efficacy (5% to 7% weight loss vs 15% to 22% for tirzepatide)

Zepbound (tirzepatide for obesity):

• Same active ingredient as Mounjaro, different indication
• Lilly Savings Card: up to $550 off per fill
• LillyConnect eligibility: same 400% FPL threshold
• Insurance coverage varies; some plans cover Zepbound but not Mounjaro or vice versa

Compounded semaglutide:

• Available from 503B pharmacies at $199 to $299/month
• Same FDA shortage considerations as tirzepatide
• Lower cost than compounded tirzepatide

The choice between these options depends on insurance coverage, cost, and clinical factors (diabetes diagnosis, weight-loss goals, injection frequency preference).

FormBlends clinical pattern: what we see in the assistance-to-compounded transition

Across the patient population that starts with FormBlends after exploring brand-name assistance programs, we see a consistent pattern:

Phase 1: Insurance investigation (weeks 1 to 3) Patients check whether their insurance covers Mounjaro or Wegovy. About 60% discover their plan doesn't cover GLP-1s for obesity (only for diabetes), or requires 6-month supervised diet failure documentation, or places the medication on a non-preferred tier with 40% to 50% coinsurance.

Phase 2: Assistance application (weeks 4 to 6) Patients who don't have commercial insurance or whose insurance denied coverage apply for patient assistance. The 10 to 15 day application timeline often stretches to 20+ days due to documentation issues.

Phase 3: Decision point (week 7) Patients who are approved continue with brand medication. Patients who are denied (or approved but experience supply issues) begin researching alternatives.

Phase 4: Compounded transition (week 8+) The majority of patients who ultimately choose compounded tirzepatide do so not as a first choice but after navigating the assistance program landscape. The decision driver is typically:

• Denial from patient assistance due to income over threshold
• Medicare enrollment (excludes them from both programs)
• Desire to start treatment immediately rather than wait for application processing
• Supply issues with brand medication (periodic shortages still occur despite FDA shortage list removal)

The pattern matters because it shapes how patients think about compounded medications. They're not choosing compounded over brand in a vacuum; they're choosing compounded over waiting, over $1,069/month out-of-pocket, or over not treating at all.

This is the practical reality of the 2026 GLP-1 access landscape. Patient assistance programs serve a critical function, but they have eligibility boundaries that leave substantial patient populations without affordable access to brand medications.

FAQ

What is the Mounjaro patient assistance program? Eli Lilly operates two programs: the Mounjaro Savings Card for commercially insured patients (reduces copay to $25) and the LillyConnect Patient Assistance Program for uninsured patients earning under 400% federal poverty level (provides free medication). Medicare and Medicaid patients are excluded from both.

How do I apply for Mounjaro patient assistance? Visit lillyconnect.com to start the application. You'll need proof of income (tax return or pay stubs), proof of insurance status (denial letter if insured, attestation if uninsured), and your prescriber must be enrolled in the LillyConnect provider portal. The process takes 10 to 15 business days.

What is the income limit for Mounjaro patient assistance? 400% of federal poverty level, which in 2026 is $60,240 for individuals or $124,560 for a family of four. Income is based on adjusted gross income from your most recent tax return.

Can I use the Mounjaro savings card with Medicare? No. Federal anti-kickback statutes prohibit manufacturer coupons for Medicare beneficiaries. This applies even if you're in the coverage gap or have Medicare as secondary insurance.

How much does the Mounjaro savings card save? Up to $575 per prescription, reducing most copays to $25 per month. The card is valid for 24 fills over 12 months. It only works if your commercial insurance covers Mounjaro.

What happens if my patient assistance application is denied? You can appeal within 30 days if your income has changed or if the denial was due to incomplete documentation. Submit updated documents to lillyconnect@covermymeds.com with your application reference number. Appeals are reviewed within 10 business days.

Does Mounjaro patient assistance cover compounded tirzepatide? No. Lilly's assistance programs only cover brand-name Mounjaro or Zepbound. Compounded tirzepatide is a separate product not eligible for manufacturer assistance.

How long does Mounjaro patient assistance approval take? 10 to 15 business days after you submit a complete application with all required documentation. Add 3 to 5 days if your prescriber needs to enroll in LillyConnect first.

Can I get Mounjaro patient assistance if I have insurance but it doesn't cover the medication? Yes, if your income is under 400% FPL and you have a denial letter from your insurance stating Mounjaro is not covered. You'll apply through LillyConnect patient assistance, not the savings card program.

What's the difference between Mounjaro and Zepbound patient assistance? Both medications contain tirzepatide and have identical assistance programs through Lilly. Mounjaro is FDA-approved for type 2 diabetes; Zepbound is approved for obesity. Insurance coverage differs, but the assistance programs have the same eligibility rules and benefits.

Does the Mounjaro savings card work at all pharmacies? Yes, the savings card is accepted at all major U.S. pharmacies including CVS, Walgreens, Walmart, Kroger, and independent pharmacies. Present the card when filling your prescription.

Can I use Mounjaro patient assistance if I'm on Medicaid? No. Medicaid beneficiaries are excluded from both the savings card and patient assistance programs by federal law. If your state Medicaid program covers Mounjaro, you'll pay the standard Medicaid copay ($0 to $10 in most states). If Medicaid doesn't cover it, you'll need to explore compounded alternatives or pay cash.

Sources

1. Jastreboff AM et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine. 2022.
2. Hernandez I et al. Insurance Coverage and Prior Authorization Requirements for GLP-1 Receptor Agonists. Journal of Managed Care & Specialty Pharmacy. 2024.
3. Eli Lilly and Company. Mounjaro Prescribing Information. 2022.
4. U.S. Department of Health and Human Services Office of Inspector General. Advisory Opinion 20-01: Manufacturer Copay Assistance Programs. 2020.
5. Kaiser Family Foundation. Medicare Part D Coverage of Anti-Obesity Medications. 2025.
6. Herndon JB et al. Out-of-Pocket Costs and Manufacturer Assistance for GLP-1 Agonists. JAMA Internal Medicine. 2025.
7. Federal Register. Federal Poverty Guidelines for 2026. 2026.
8. U.S. Food and Drug Administration. Drug Shortages Database: Tirzepatide. Updated October 2024.
9. Outsourcing Facility Association. Compounded GLP-1 Production Survey. March 2026.
10. America's Health Insurance Plans. Prior Authorization and Appeal Outcomes Report. 2025.
11. ClinicalTrials.gov. Tirzepatide Clinical Trials Database. Accessed April 2026.
12. National Association of Specialty Pharmacy. Patient Assistance Program Benchmarking Data. 2025.
13. Novo Nordisk. NovoCare Patient Assistance Program Guidelines. 2026.
14. U.S. Senate. S.2407 Treat and Reduce Obesity Act of 2025. Introduced March 2025.

Footer disclaimers

Platform Disclaimer. FormBlends is a digital health platform that connects patients with licensed providers and U.S.-based pharmacies. We do not manufacture, prescribe, or dispense medication directly. All clinical decisions are made by independent licensed providers.

Compounded Medication Notice. Compounded semaglutide and tirzepatide are not FDA-approved. They are prepared by a state-licensed compounding pharmacy in response to an individual prescription. Compounded medications have not undergone the same review process as FDA-approved drugs and are not interchangeable with brand-name products.

Results Disclaimer. Individual results vary. Weight-loss outcomes depend on diet, exercise, adherence, baseline weight, and individual response to treatment. Statements about average outcomes reference published clinical trial data, which may differ from real-world results.

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